P001196.B
AtriClip® Flex•V™ LAA Exclusion System
with Preloaded V•Clip
(ACHV35, ACHV40, ACHV45, ACHV50)
Instructions for Use
PACKAGE CONTENTS
AtriClip Flex•V LAA Exclusion System
V Clip
RECOMMENDED ACCESSORIES
Gillinov-Cosgrove™ Selection Guide
DESCRIPTION
The AtriClip Flex•V LAA Exclusion System contains a V Clip for open
occlusion of the heart’s left atrial appendage (LAA). The Clip is pre-loaded
on a disposable Clip applier. The Flex•V LAA Exclusion System with
preloaded V Clip does not contain natural rubber latex components.
AtriClip Flex•V LAA Exclusion System
ILLUSTRATION AND NOMENCLATURE
1. V Clip
5. Shaft Rotation Knob
2. Clip Opening Jaws
6. Deployment Trigger
3. End Effector
7. Activation Lever
4. Shaft
1
8. Handle
1
The entire length of the shaft is malleable and intended for adjustments
up to 45 degrees in any direction.
BEFORE USING PRODUCT READ THE FOLLOWING
INFORMATION THOROUGHLY
IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference
to surgical techniques.
INDICATION FOR USE
The AtriClip LAA Exclusion System is indicated for the occlusion of
the heart’s left atrial appendage, under direct visualization and in
conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able
to see the heart directly, with or without assistance from a camera,
endoscope, etc., or any other viewing technology.
CONTRAINDICATIONS
Do not use this device as a contraceptive tubal occlusion device.
WARNINGS
1. Do not attempt to reposition or remove the Clip after deployment.
This may result in tissue damage or tearing.
2. Use this device only as intended. Failure to do so may result in injury
to the user or patient.
3. Do not use on tissue which, in the opinion of the surgeon, would not
be able to tolerate conventional suture materials or conventional
closure techniques (such as surgical stapling). Doing so may result in:
tissue trauma, dehiscence, tissue tearing, displacement and/or lack of
desired homeostasis.
4. Carefully evaluate Clip position, tissue thickness, and tissue width
prior to Clip deployment. To determine appropriate Clip size, refer to
the Gillinov-Cosgrove Selection Guide Instructions for Use. Failure
to correctly size or deploy the Clip may result in: tissue trauma,
dehiscence, tissue tearing, displacement and/or lack of desired
homeostasis.
5. Do not use on a LAA less than 29mm in width and 1.0mm wall
thickness. Doing so may result tissue in: trauma, dehiscence, tissue
tearing, displacement and/or lack of desired homeostasis.
6. Do not use on a LAA greater than 50mm when tissue is
uncompressed. Doing so may result in incomplete occlusion of the
structure.
PRECAUTIONS
1. Federal Law (USA) restricts this device to sale by or on the order of a
physician.
2. Use of the device should be limited to properly trained and qualified
medical personnel.
3. Read all instructions carefully for the AtriClip Flex•V LAA Exclusion
System. Failure to properly follow instructions may result in improper
functioning of the device.
4. Note that variations in specific procedures may occur due to individual
physician techniques and patient anatomy.
5. Do not drop or toss the device as this may induce damage to the
device. If the device is dropped, do not use. Replace with a new
device.
6. DO NOT RESTERILIZE. The AtriClip LAA Exclusion System is provided
STERILE and is intended for SINGLE use only. Re-sterilization may
cause loss of function or injury to patient.
7. Carefully consider any pre-surgical treatment the patient may have
undergone and in corresponding selection of Clip size. Preoperative
radiotherapy may result in changes to tissue. These changes may, for
example, cause the tissue thickness to exceed the indicated range for
the selected Clip size.
8. Do not modify this instrument. Use of a modified device may result
in improper instrument function. AtriCure, Inc. makes no claim or
representation as to the performance characteristics of this product
if any modifications have been made to the AtriClip Flex•V ™ LAA
Exclusion System.
9. Do not grasp device end effector to apply bend to shaft, as this may
result in damage to the device. Excessive bending or kinking of the
shaft may affect device performance. Do not attempt to twist the
device end effector, as this may cause damage to the device.
10. Evacuate thrombus from the LAA prior to Clip application as with
other conventional LAA occlusion surgical techniques. Evaluating for
the presence of thrombus should be done per the surgeon’s discretion
and standard of care.
11. Position and deploy Clip in a manner that provides adequate
visualization of all tissues being accessed. Poor visualization may
result in suboptimal placement.
12. Take care to minimize manipulation of the LAA and Clip after Clip
deployment.
13. It is recommended that the Clip be deployed in a dry field.
14. Do not attempt to rotate the End Effector without pulling it out of the
locked position. Force applied while in the locked position may cause
damage to the device.
15. Only pull the deployment trigger when the clip is properly positioned
over the LAA. Pulling the Deployment Trigger permanently releases
the Clip from the applier.
INSTRUCTIONS FOR USE
Surgeon judgment, with the assistance of the Gillinov-Cosgrove Selection
Guide, should determine what size Clip to apply.
Clip Selection
1. Using the Gillinov-Cosgrove Selection Guide, to determine correct
selection of the LAA Clip. Clip sizes are located on the device package.
Clip Size
LAA Size Range
35 mm
29 – 35 mm
40 mm
34 – 40 mm
45 mm
39 – 45 mm
50 mm
44 – 50 mm
2. Using sterile technique, remove the AtriClip Flex•V LAA Exclusion
System from its packaging.
3. Using the Activation Lever on the handle, gently open and close the
Clip to assure proper function.
Shaft Bending
4. The AtriClip Flex•V contains a malleable shaft of that may be reshaped
to aid in accessing the LAA. Apply gentle pressure to shape the device
shaft as required for anatomical variations.
Precaution:
Do not grasp device end effector to apply bend to shaft,
as this may result in damage to the device. Apply bend by gently
concentrating force under both thumbs. Excessive bending or kinking
of the shaft may affect device performance. Do not attempt to twist
the device end effector, as this may cause damage to the device.
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